2024/25 Taught Postgraduate Module Catalogue

BMSC5221M Drug Development: from candidate to patient

15 creditsClass Size: 55

Module manager: Dr Al Pickles
Email: a.r.pickles@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) View Timetable

Year running 2024/25

Pre-requisite qualifications

Sufficient entry requirements to have been admitted to the above programme

Module replaces

BMSC5220M Drug development: preclinical

This module is not approved as an Elective

Module summary

The module will provide an outline to the principles and methods involved in a range of preclinical models used in drug development. There will be an emphasis on understanding of the practical application of these models by the detailed analysis of real examples backed up with the relevant theory to enable an understanding of how and why they are used. The module will continue into the clinical area to provide an overview and understanding of the stages involved in the progression of a candidate compound in humans covering the application of core concepts, including ethical and regulatory constraints, underpinning clinical trials in humans, using real world tasks & activities.

Objectives

The objectives are to provide a broad yet detailed understanding of the various approaches and techniques applied in preclinical drug development from preclinical through to licenced drugs used in patients. This will include the efficacy and safety/toxicity testing of novel compounds prior to first time in man (clinical trials) and continue into understanding and application of core concepts underpinning clinical trials in humans. This module will also promote knowledge relating to the application of clinical trials to clinical practice, with the use of workshops to include elements of education for sustainable development, equity, diversity and inclusivity and decolonisation.

Learning outcomes
On completion of this module students should be able to:
1. Relate the many stages and ranges of animal models used in preclinical drug development
2. Discuss the theories and rationale of the use of animals in drug development including considerations of the requirements of different species
3. Explain specific preclinical methods employed in efficacy testing, safety pharmacology and toxicological testing
4. Explain the considerations and processes underlying the four phases of clinical trials conducted in humans
5. Construct, ethically sound components of a drug development plan from preclinical to clinical trial protocol
6. Relate the ethical issues surrounding drug development, in both the Global North and South.

Syllabus

• Preclinical efficacy testing in animals
• In-vivo DMPK and Safety pharmacology including non-clinical abuse liability
• Toxicological screening including cancer biology testing
• Key principles of phase I to phase IV clinical trials
• Elements of clinical trial protocols including alignment with ICH GCP
• Clinical trial data collection and interpretation
• Clinical guidelines (e.g. NICE) and clinical practice (e.g. prescribing) outcomes resulting from clinical trials
• Post-marketing surveillance of registered drugs
• Ethical and regulatory issues and constraints on drug development

Teaching methods

Private study hours			128.00
Total Contact hours			0.00
Total hours (100hr per 10 credits)			128.00

Private study

Students will be provided with essential content and information in workshops and screencasts. They will supplement this knowledge, as required from publicly available research and educational resources, and apply it, as a team, in the development of a research proposal for a preclinical research study.

Opportunities for Formative Feedback

Students will receive extensive guidance and instruction in the workshops with regular Q&A opportunities to gain feedback on their research plans and approaches.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Report	Individual outline research plan/proposal to develop a defined piece of work encompassing preclinical and clinical development of a novel compound, medical device or disease mechanism	30.00
Group Project	A research plan/proposal to develop a defined piece of work encompassing preclinical and clinical development of a novel compound, medical device or disease mechanism.	40.00
Presentation	Presentation of research proposal; individually assessed	30.00
Total percentage (Assessment Coursework)		100.00

Alternative resit will be required for any student that has not engaged and/or contributed to the generation of the group project and presentation. The resit would be expected to be of a similar approach however with an alternative focus of the central research plan.

Reading list

There is no reading list for this module

Last updated: 29/04/2024 16:10:51

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